Unique ID issued by UMIN | UMIN000010678 |
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Receipt number | R000012487 |
Scientific Title | Phase II study of gemcitabine, S-1, leucovorin combination therapy for advanced biliary tract cancer |
Date of disclosure of the study information | 2013/05/15 |
Last modified on | 2022/05/19 22:03:11 |
Phase II study of gemcitabine, S-1, leucovorin combination therapy for advanced biliary tract cancer
Phase II study of GSL combination therapy for advanced biliary tract cancer
Phase II study of gemcitabine, S-1, leucovorin combination therapy for advanced biliary tract cancer
Phase II study of GSL combination therapy for advanced biliary tract cancer
Japan |
Unresectable or recurrent biliary tract cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate the efficacy and safety of GEM+S-1+LV combination therapy for advanced biliary tract cancer.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Progression-free survival
Overall survival, response rate, adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
GEM+S-1+LV combination therapy
GEM: 1,000mg/m2, day1
S-1: 80mg/day(BSA<1.25/m2)
100mg/day(1.25/m2=<BSA<1.5/m2)
120mg/day(BSA=>1.5/m2), day1-7
LV: 50mg/day, day1-7
repeated every 2 weeks.
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients with unresectable or post-operative recurrent biliary tract cancer
2) Patients with pathologically proven biliary tract cancer
3) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2
4) Patients of age >= 20 years
5) Patients have an ability for a sufficient oral intake
6) Patients have an adequate organ function defined as white cell count >= 3,000/mm3, neutrophil >= 1,500/mm3, platelet count >= 100,000/mm3, hemoglobin >= 9g/dl, total bilirubin <= 3 times the upper limit of normal, AST and ALT <= 5 times the upper limit of normal, creatinine <= 1.5 times the upper limit of normal, normal echocardiogram
7) Patients who expect to survive more than two months.
8) Written informed consent is required from all patients.
1) Patients with a previous history of a severe drug hypersensitivity
2) Patients with an active concomitant infection
3) Patients with severe comobidities (cardiovascular disease, renal failure, hepatic failure, digestive ulcer, and gastrointestinal bleeding).
4) Patients with an active pulmonary fibrosis or interstitial pneumonia
5) Patients with severe diahrrea
6) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception
7) Patients with uncontrollable massive pleural effusion or massive ascites
8) Patients with an active concomitant malignancy
9) Inappropriate patients for entry on this study in the judgement of the investigator
45
1st name | |
Middle name | |
Last name | Hiroyuki Isayama |
The University of Tokyo Hospital
Department of Gastroenterology
7-3-1, Hongo, Bunkyo-ku, Tokyo
03-3815-5411
isayama-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Naminatsu Takahara |
The University of Tokyo Hospital
Department of Gastroenterology
7-3-1, Hongo, Bunkyo-ku, Tokyo
03-3815-5411
takaharan-int@h.u-tokyo.ac.jp
The University of Tokyo Hospital
None
Self funding
NO
東京大学医学部附属病院(東京都)
2013 | Year | 05 | Month | 15 | Day |
Unpublished
Terminated
2013 | Year | 04 | Month | 30 | Day |
2013 | Year | 05 | Month | 13 | Day |
2013 | Year | 06 | Month | 01 | Day |
2018 | Year | 03 | Month | 31 | Day |
2013 | Year | 05 | Month | 09 | Day |
2022 | Year | 05 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012487
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